Regulation

Elad Walach, cofounder and CEO of Aidoc
By  Emily Olsen 03:01 pm April 6, 2022
Aidoc scored a second FDA 510(k) clearance last month for artificial intelligence software aimed at finding and triaging potential brain aneurysms in CT scans.  According to the FDA's database, the agency gave the green light on the tool around the same time in March as it did Aidoc's algorithm for flagging pneumothorax, or a collapsed lung, on X-rays. That clearance was announced last week. ...
A doctor looking at a chest x-ray
By  Emily Olsen 01:47 pm March 30, 2022
Radiology artificial intelligence company Aidoc scored FDA 510(k) clearance for its tool for flagging and triaging cases of pneumothorax, or a collapsed lung, on X-rays. Aidoc said the software could run on all X-rays, including portable machines, and automatically notes positive cases of pneumothorax so physicians can focus on these images more quickly.  Some of Aidoc's other FDA-cleared tools...
Clinicians
By  Laura Lovett 01:04 pm March 22, 2022
With hundreds of thousands of health apps on the market today, choosing the right one can be confusing for patients. Countries all over the world are looking to help their citizens navigate the process. Governments are increasingly moving towards a centralized approach for digital health regulation and reimbursement, according to a new article in Nature.  "We found that most approaches aim for...
A close up of a person wearing the Cionic Neural Sleeve
By  Emily Olsen 01:36 pm March 8, 2022
Cionic scored FDA 510(k) clearance for its Neural Sleeve, a legging that provides electrical stimulation so people with foot drop and muscle weakness can walk more easily. The leg-worn device, which officially received the green light from the agency in mid-February, is aimed at people with neurological conditions like multiple sclerosis, stroke and cerebral palsy. The sleeve's electrical...
An image of the software detecting a fracture near a patient's hip
By  Emily Olsen 04:15 pm March 2, 2022
French imaging AI company GLEAMER scored FDA 510(k) clearance for its software designed to identify fractures in X-rays. BoneView uses artificial intelligence to detect potential fractures and sends results to radiologists for confirmation. The software received a CE mark in Europe in March 2020. "In the value-based U.S. healthcare system, providers tell us they want to improve the radiographic...
FDA
By  Laura Lovett 01:36 pm February 24, 2022
Artificial intelligence care coordination company Viz.ai landed an FDA 510(k) clearance for its new algorithm designed to detect cerebral aneurysms. Dubbed Viz Aneurysm, the technology was designed to pinpoint the condition from CT scans. The new algorithm will fit into Viz Intelligent Care Coordination Platform, and be used to help streamline getting detected aneurysm into the clinical workflow...
By  Laura Lovett 12:19 pm February 21, 2022
Abbott's implantable cardiac sensor system CardioMEMS landed an expanded FDA clearance, allowing earlier stage heart failure patients to use the tech.  The system, which is designed to monitor pressure changes in the heart, is implanted in a patient's pulmonary artery during a minimally invasive procedure. The connected sensor is able to send data daily to doctors and care teams about a patient's...
An older man wearing headphones checking his smartphone
By  Emily Olsen 12:14 pm February 14, 2022
Continuous glucose monitoring system maker Senseonics has won FDA approval for its Eversense E3, which can be used to measure glucose levels in adults with diabetes for up to six months. The system works using a sensor that is implanted just under the skin by a healthcare provider. A transmitter worn over the sensor, on top of the skin, receives glucose data, provides vibratory alerts and...
AliveCor screen
By  Laura Lovett 11:27 am February 1, 2022
AliveCor is rolling out a new credit-card-size personal ECG called the KardiaMobile Card. The technology, which landed FDA clearance in November, is able to take a single-lead ECG in 30 seconds. The Bluetooth-backed technology is able to pair with a smartphone and detect six types of arrhythmias including; AFIB, Bradycardia, Tachycardia, PVCs, Sinus Rhythm with SVE and Sinus Rhythm with Wide QRS...
The Omnipod 5 system including the Dexcom G6 and the smartphone app
By  Emily Olsen 02:17 pm January 31, 2022
Insulin pump-maker Insulet has scored FDA 510(k) clearance for its Omnipod 5 Automated Insulin Delivery System for people ages 6 and up with Type 1 diabetes. The pump integrates with the Dexcom G6 continuous glucose monitor to automatically adjust insulin levels depending on blood glucose. It can be worn for up to 72 hours. Users can control their pump and share data from an app if they have a...